E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | HLGT |
E.1.2 | Classification code | 10027412 |
E.1.2 | Term | Mesotheliomas |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10027406 |
E.1.2 | Term | Mesothelioma |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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E.1.3 | Condition being studied is a rare disease | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Comparar la supervivencia global asociada a vorinostat más la mejor asistencia de apoyo con la supervivencia asociada a placebo más la mejor asistencia de apoyo para el tratamiento de los pacientes con mesotelioma pleural maligno avanzado que no han respondido al menos a una pauta de quimioterapia previa, y determinar la seguridad global y la toxicidad de vorinostat en esta población |
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E.2.2 | Secondary objectives of the trial |
Comparar vorinostat más la mejor asistencia de apoyo con placebo más la mejor asistencia de apoyo para el tratamiento de los pacientes con mesotelioma pleural maligno avanzado que no han respondido al menos a una pauta de quimioterapia previa con respecto a: a.Supervivencia sin progresión b.Tasa de respuesta objetiva global c.Puntuación de la disnea en la escala de síntomas del cáncer pulmonar modificada para el mesotelioma (LCSS Meso) en la semana 12; y d.Cambio porcentual con respecto al valor basal en la capacidad vital forzada (FVC) en la semana 12. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patient must have a histologically and/or cytologically confirmed diagnosis of epithelial, sarcomatoid, or mixed histology malignant pleural mesothelioma, which has progressed or relapsed following standard treatment which included pemetrexed in combination with either cisplatin or carboplatin. The most recent regimen must have contained pemetrexed Patient has had no more than one previous systemic therapy regimen other than pemetrexed in combination with cisplatin or carboplatin; the most recent regimen must have contained pemetrexed Patient must have at least 1 lesion that can be measured by using the modified RECIST [10], i.e., is at least 1.5 cm in diameter on a spiral computerized tomography (CT) scan. |
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E.4 | Principal exclusion criteria |
Pacientes que hayan recibido tratamiento previo con un inhibidor de la HDAC (p. ej., depsipéptido, MS 275, LAQ 824, PXD 101 y ácido valproico). Los pacientes que hayan recibido dichos fármacos para otras indicaciones, por ejemplo, epilepsia, podrán participar en ensayos de vorinostat tras un período de lavado de 30 días.Pacientes con infección activa para la que hayan recibido antibióticos, antivirales o antifúngicos por vía intravenosa en las dos semanas anteriores al comienzo del fármaco del estudio.Los pacientes con una segunda neoplasia maligna actualmente activa" distinta de cáncer de piel que no sea melanoma y del carcinoma de cuello uterino in situ serán excluidos. Se considerará que el paciente no tiene una segunda neoplasia maligna "actualmente activa si ha completado el tratamiento para el segundo tumor maligno y no ha presentado la enfermedad maligna previa en los últimos > 5 años.Pacientes con metástasis cerebrales no controladas, por ejemplo, metástasis cerebrales tratadas previamente que no se hayan estabilizado en las últimas 6 semanas. |
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E.5 End points |
E.5.1 | Primary end point(s) |
La variable de eficacia principal será la supervivencia. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | Yes |
E.6.12 | Pharmacoeconomic | Yes |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 4 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 39 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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El primer análisis intermedio se realizará cuando 50 pacientes hayan alcanzado el seguimiento a las 18 semanas. El segundo análisis intermedio se llevará a cabo cuando se hayan producido unas 135 muertes. El tercer análisis intermedio se llevará acabo cuando se hayan producido unos 270 fallecimientos. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | 2 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 2 |
E.8.9.2 | In all countries concerned by the trial days | 0 |